- September 28, 2021
9:00 AM - 2:00 PM ET
The Food and Drug Administration (FDA or Agency) is announcing a virtual public meeting to discuss proposed recommendations for the reauthorization of the Prescription Drug User Fee Act (PDUFA) for fiscal years (FYs) 2023 through 2027. The virtual public meeting will be held on September 28, 2021, from 9 a.m. to 2 p.m. (ET). The meeting agenda, public docket information, additional materials, and any other updates will also be posted to this website as they become available.
You can register for the meeting here to let FDA know that you plan to attend. Though registration is voluntary and not required to attend, registrants will receive email updates and notices when new information becomes available.
Date: September 28, 2021
Time: 9:00 AM - 2:00 PM ET
Webinar Meeting ID:
161 932 6064
Webinar Password (Case-Sensitive):
Register for this Event
Please submit any comments or feedback regarding the proposed enhancements to the PDUFA program at the Federal Register Notice link below. To submit your comment, click the green button at the top of the page on the right-hand side that reads “Submit a formal comment.” You may also upload files (e.g. slides). All comments are considered part of the public record and will be publicly available.
- Dr. Woodcock's Opening Remarks (YouTube Video)
- To view the webinar recording of this public meeting, please click on this link
|PDUFA VII Public Meeting Agenda 09.28.21||pdf (131.71 KB)|
|PDUFA VII Commitment Letter||pdf (452.93 KB)|
|PDUFA VII Public Meeting Slides 09.28.21||pdf (1.57 MB)|
|PDUFA VII Public Meeting Transcript 09.28.21||pdf (720.38 KB)|
|PDUFA VII Opening Remarks Transcript 09.28.21||pdf (50.08 KB)|
|PDUFA VII Public Docket Summary 09.28.21||pdf (163.80 KB)|